HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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Model Number 1104 |
Device Problem
Increase in Suction (1604)
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Patient Problem
Dehydration (1807)
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Event Date 09/13/2020 |
Event Type
Injury
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Manufacturer Narrative
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This regulatory report is being submitted as part of a retrospective review and remediation per d00595825 due to an fda audit observation.Product event summary: (b)(4) was not returned for evaluation.The reported suction alarm was confirmed via log file analysis which revealed nineteen (19) suction alarms between (b)(6) 2020 and (b)(6) 2020.Information provided by the site indicated that the patient had no subjective symptoms.The patient was instructed to drink plenty of water.However, the instruction was not being followed well.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported suction event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or poor vad filling, and/or patient related factors.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.
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Event Description
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It was reported that review of logfiles showed multiple ventricular assist device (vad) suction alarms.It was noted that the patient had no subjective symptoms.The patient was instructed to drink plenty of water because they become dehydrated early in the morning.However, the instruction was not being followed well.The vad remains in use.No further patient complications have been reported as a result of this event.
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Event Description
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It was reported that review of logfiles showed multiple ventricular assist device (vad) suction alarms.It was noted that the patient had no subjective symptoms.The patient was instructed to drink plenty of water because they become dehydrated early in the morning.However, the instruction was not being followed well.The vad remains in use.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.Product event summary: (b)(4) was not returned for evaluation.The reported suction alarm was confirmed via log file analysis which revealed nineteen (19) suction alarms between 09/sep/2020 and 04/oct/2020.Information provided by the site indicated that the patient had no subjective symptoms.The patient was instructed to drink plenty of water.However, the instruction was not being followed well.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported suction event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or poor vad filling, and/or patient related factors.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.
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